Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209410
Company: SUPERNUS PHARMS

Products on NDA 209410

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 129MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 193MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 258MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
OSMOLEX ER	AMANTADINE HYDROCHLORIDE	EQ 161MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209410

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209410s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209410Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209410Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2025	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209410s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209410Orig1s009ltr.pdf

Labels for NDA 209410

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209410s009lbl.pdf
02/16/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209410s000lbl.pdf